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NCT06563856 · ClinicalTrials.gov registry record · Phase 1
A Study of TEPEZZA Subcutaneous Administration in Healthy Adults
A Phase 1 study of Bioavailability and Bioequivalence, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
- 1
- Study location
NCT06563856 is a Phase 1 study of Bioavailability and Bioequivalence that has completed, run by Amgen. The registered enrollment target is 37 participants, roughly in line with the 34-participant average among 8 other Bioavailability trials with a reported enrollment target. The trial reports 1 study location across 1 state.
The verdict
NCT06563856, a Phase 1 study of Bioavailability and Bioequivalence, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of this study is to assess the pharmacokinetics (PK) parameters of a single subcutaneous (SubQ) infusion of TEPEZZA with and without ENHANZE™ Drug Product (EDP) at 2 dose levels in healthy adult participants.
Conditions Studied
Interventions
- DRUG TEPEZZA
- DRUG EDP
Study Locations (1)
Nevada
- PPD Development - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2020-09-22 |
| Est. Completion | 2021-05-27 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06563856
The ClinicalTrials.gov registry entry for NCT06563856 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 34-participant average among 8 other Bioavailability trials with a reported enrollment target. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Bioavailability appearing as the primary indexed condition, and to 2 interventions - of which TEPEZZA is the first listed.
NCT06563856 reports 1 study location spanning 1 distinct geographic area - top geographies include Nevada.
Frequently Asked Questions
What is clinical trial NCT06563856 about?
NCT06563856 is a clinical study titled "A Study of TEPEZZA Subcutaneous Administration in Healthy Adults". The primary objective of this study is to assess the pharmacokinetics (PK) parameters of a single subcutaneous (SubQ) infusion of TEPEZZA with and without ENHANZE™ Drug Product (EDP) at 2 dose levels in healthy adult participants.
What is the current status of trial NCT06563856?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2020-09-22. Estimated completion is 2021-05-27.
What conditions does trial NCT06563856 study?
This clinical trial studies the following conditions: Bioavailability, Bioequivalence.
What interventions are being tested in trial NCT06563856?
The interventions under investigation include: TEPEZZA (DRUG), EDP (DRUG).
Who is sponsoring clinical trial NCT06563856?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06563856 being conducted?
This trial has 1 study location across Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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